JLK-NCCT— 510(k) K252421
Substantially EquivalentJLK, Inc.
FDA 510(k) clearance K252421 for JLK-NCCT, Substantially Equivalent on 2026-03-24. Applicant: JLK, Inc.. Device class: 2.
Summary
JLK's JLK-NCCT is filed under QAS, radiological computer-assisted triage and notification software. The record doesn't describe the software beyond its name and that code name.
Class II, 21 CFR 892.2080. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
JLK filed from Seoul, South Korea. Review took 235 calendar days (August 1, 2025 to March 24, 2026).
Clearance details
- Applicant
- JLK, Inc.
- Product code
- Product code QAS
- Device class
- Class 2
- Regulation
- 21 CFR 892.2080
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seoul, KR
Recent devices under product code QAS
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